Food and Drug Administration (FDA) shared on LinkedIn:
“Today, FDA published 55 product-specific guidances (PSGs) to accelerate generic drug development and increase competition, including 30+ for products that currently have no approved generics.
They address products such as:
- Targeted oncology oral kinase inhibitors approved for specific types of non-small cell lung cancer.
- First-in-class dipeptidyl peptidase 1 (DPP1) inhibitor, the first and currently only approved treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and adolescents.
- A poly (ADP-ribose) polymerase (PARP) inhibitor representing a pioneering approval, particularly for BRCA-mutated cancers.
When finalized, PSGs reflect FDA’s current thinking for developing generic drug products and generating evidence to support FDA approval of these products. FDA publishes PSGs to help facilitate generic drug development, streamline ANDA assessment, and support greater access to generic drugs that are as safe and effective as their brand name counterparts and meet the same high-quality standards.”
Other articles about FDA on OncoDaily.
